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High-Fiber Supplement for Multiple Sclerosis

Phase 1 & 2
Waitlist Available
Research Sponsored by Suhayl Dhib-Jalbut, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with first demyelinating event who meet the McDonald criteria for definite MS or established relapsing remitting MS patients.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented progression, assessed up to 36 months
Awards & highlights

Study Summary

This trial will examine the effect of a specially designed high-fiber supplement on the growth of short-chain fatty acid-producing gut bacteria and development of regulatory immune cells in people with MS.

Who is the study for?
This trial is for Caucasian individuals with a first demyelinating event meeting McDonald criteria for MS or established relapsing-remitting MS, treated with Glatiramer acetate or Fingolimod. Excluded are pregnant women, those who've had chemotherapy or taken DMF, have progressive MS, allergies to the supplement's ingredients, other autoimmune diseases, cognitive impairments, recent antibiotic or probiotic use.Check my eligibility
What is being tested?
The study tests a high-fiber supplement (NBT-NM108) at 60 g/day versus no supplement in managing Multiple Sclerosis by promoting healthy gut bacteria growth and regulatory immune cells. It also explores fecal Lcn-2 as a non-invasive biomarker for gut dysbiosis-mediated CNS autoimmunity in MS.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include gastrointestinal discomfort such as bloating and gas due to increased fiber intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with multiple sclerosis following my first demyelinating event.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented progression, assessed up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first documented progression, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of high-fiber supplement (HFS) on (1) composition of gut microbiota and (2)production of short-chain fatty acids (SCFAs) and Foxp3 regulatory T cells (Tregs).
Examine fecal Lcn-2 levels before/after MS relapse

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort A: Treatment with NBT-NM108�Experimental Treatment1 Intervention
Patients will receive NBT-NM108 at 60 g/day for 8 weeks.
Group II: Cohort B: Non-treatmentPlacebo Group1 Intervention
Patients will not receive NBT-NM108.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Suhayl Dhib-Jalbut, MDLead Sponsor

Media Library

NBT-NM108 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04574024 — Phase 1 & 2
Multiple Sclerosis Research Study Groups: Cohort A: Treatment with NBT-NM108�, Cohort B: Non-treatment
Multiple Sclerosis Clinical Trial 2023: NBT-NM108 Highlights & Side Effects. Trial Name: NCT04574024 — Phase 1 & 2
NBT-NM108 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574024 — Phase 1 & 2
~0 spots leftby Jun 2024
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